Policy & Regulation
Acerus Publishes Study Results Demonstrating Effectiveness of Natesto Regardless of Baseline Symptom Severity
10 July 2019 - - Canada-based Acerus Pharmaceuticals Corp. (TSX: ASP) (OTCQB: ASPCF) has had a new manuscript accepted to the Journal of the Endocrine Society, describing how Natesto achieves similar symptom improvement, regardless of the degree of a patient's baseline testosterone deficiency, the company said.
This new scientific report describes a post-hoc analysis of data from the pivotal Phase 3 study of Natesto, which enrolled 306 patients from 52 sites in the United States, who were treated with Natesto for up to 1 year.
Patient data from the phase 3 study was classified based on the degree of testosterone deficiency demonstrated by patients at study entry.
Each dose of Natesto resulted in a short-term return of testosterone to the upper normal range (800 ng/dL; 28 nmol/L) irrespective of how low the patient's baseline testosterone was prior to the study.
In the patient group with the lowest baseline testosterone level, a mean average serum testosterone level of 295 ng/dL (10.2 ng/dL) was achieved with Natesto exposure.
As well, statistically significant improvements in symptom relief (erectile function, mood and lean body mass) were observed in these patients.
In between Natesto doses, all patients in the phase 3 study maintained their natural testosterone at the same levels they had prior to entry into the study, indicating that Natesto does not suppress natural testosterone production.
Based on the data, Acerus believes that the mechanism of action of Natesto is unique whereby the peaks in testosterone generated by Natesto dosing provide efficacy and improvement of symptoms, while the time between doses (4-8 hours) allows for the maintenance of testicular testosterone production and sperm production.
Natesto is a nasal gel formulation of testosterone developed by Acerus Pharmaceutical Corp. and indicated as a replacement therapy for men diagnosed with conditions associated with a deficiency or absence of endogenous testosterone (hypogonadism).
It is the first and only nasally-administered testosterone product approved by the US FDA, Health Canada and South Korea and available in a 'no-touch' dispenser with a metered dose pump.
Acerus Pharmaceuticals Corp. is a Canadian-based specialty pharmaceutical company focused on the commercialization and development of innovative prescription products that improve patient experience, with a primary focus in the field of men's health.
The company commercializes its products via its own salesforce in Canada, and through a global network of licensed distributors in the US and other territories.
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